CTRI/2021/12/038622尚未招募2 期
An International Multicenter, Adaptive, Randomized Double-Blind, Placebo- Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19 - ITAC
niversity of Minnesota0 个研究点目标入组 500 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. SARS-CoV-2 infection documented by PCR or other nucleic acid test (NAT) within 3 days prior to randomization OR documented by NAT more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection
- •2. Symptomatic COVID-19 disease
- •3. Duration of symptoms attributable to COVID-19 ââ?°Â¤ 12 days
- •4.Requiring in patient hospital medical care for clinical manifestations of COVID-19 (admission for public health or quarantine only is not included)
- •5.Age ââ?°Â¥ 18 years
- •6. Willingness to abstain from participation in other COVID-19 treatment trials until after study Day 7
- •7. Provision of informed consent by participant or legally authorized representative
排除标准
- •1.Prior receipt of SARS-CoV-2 hIVIG or convalescent plasma from a person who recovered from COVID-19 at any time
- •2. Prior receipt of standard IVIG (not hyperimmune to SARS-CoV-2) within 45 days
- •3.Current or predicted imminent (within 24 hours) requirement for any of the following:
- •Ã¢â?¬Â¢ Invasive ventilation
- •Ã¢â?¬Â¢ Non-invasive ventilation
- •Ã¢â?¬Â¢ Extracorporeal membrane oxygenation
- •Ã¢â?¬Â¢ Mechanical circulatory support
- •Ã¢â?¬Â¢ Continuous vasopressor therapy
- •4. History of allergy to IVIG or plasma products
- •5. History of selective IgA deficiency with documented presence of anti-IgA antibodies
- •6. Any medical conditions for which receipt of the required volume of intravenous fluid may be dangerous to the patient
- •Ã¢â?¬Â¢ Includes New York Heart Association Class III or IV stage heart failure
- •7. Any of the following thrombotic or procoagulant disorders:
- •Ã¢â?¬Â¢ Acute coronary syndromes, cerebrovascular syndromes and pulmonary or
- •deep venous thrombosis within 28 days of randomization
- •Ã¢â?¬Â¢ History of prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antithrombin III deficiency, protein C deficiency, protein S deficiency or antiphospholipid syndrome
- •8.Any condition for which in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
研究者
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